In the care of patients afflicted with wounds to the flesh, such as, cuts, burns, bruises, ulcerations, lacerations, and the like, the extent of wound healing over time is monitored by measuring the surface area of the wound on a regular, periodic basis. Further, the proper evaluation of wound management products and therapies also requires the extent of wound healing to be monitored on a regular, periodic basis.
Wound monitoring, both for determining healing and the effectiveness of wound management products, has traditionally involved first recording the surface area of the untreated wound on a single transparent plastic sheet. Printed on one side of that sheet is wound sizing indicia, e.g., a grid or bulls-eye. The area of the wound is typically recorded by simply placing that printed sheet over the wound, and tracing the outer boundary, or periphery, of the wound with a suitable marking device. After marking, any wound debris remaining on the sheet is removed, e.g., by wiping with a suitable disinfecting or sterilizing cleanser. The size of the wound is then determined by comparing the marking with the sizing indicia. The marked sheet, which now contains a sized, graphical representation of the wound, is then placed into the patient's file for future reference.
The foregoing procedures, when repeated over a period of time, e.g., daily, creates an accurate wound history for that patient. A number of these histories assembled from different patients can be used to compare the effectiveness of new wound management products and therapies with those currently available. As a general rule, a product which effects the greatest decrease in wound area over a given period of time would be deemed more desirable as compared to a product that effected a lesser decrease in wound area over that same period of time.
The use of presently available wound marking devices, however, creates potentially serious problems for the clinician. As the device is placed over the wound, the side which faces the open wound often becomes contaminated with wound exudate, blood, necrotic tissue, and the like. Contaminated devices must be cleaned and dried, and in most cases sterilized, before they can be safely handled without gloves, or stored, e.g., in a patient's file. Contaminated devices are especially dangerous when the device has been used on a patient who has a contagious disease, such as, HIV, hepatitis, or on a patient whose body fluids harbor other types of infectious agents.
One device which purports to overcome at least the contamination problem mentioned previously is described in U.S. Pat. No. 5,265,605. This device comprises two separate transparent sheets, one being a backing sheet and the second consisting of the wound assessment sheet. The back of the wound assessment sheet is coated with an adhesive which allows it to remain tacked to the backing sheet until after the wound assessment is completed, wherein the sheets are manually separated. The device is further designed so that, after it is placed over a wound and an outline of the wound is traced thereon, the wound assessment sheet is peeled from the backing sheet and is subsequently secured onto a wound assessment worksheet by the adhesive which remains on the back of the assessment sheet. The worksheet is then placed in the patient's file for future reference.
While the foregoing device purportedly avoids contamination of the assessment sheet, it has certain drawbacks. One of these is that a caregiver is unable to place two or more assessment sheets on top of each other to directly compare one wound assessment with another because the sheets have an adhesive thereon, and further because such sheets are said to be adhered onto an assessment worksheet after use. This type of comparison is extremely helpful to a caregiver, enabling one to accurately compare the effects of wound treatment over time. Moreover, the device described in the '605 patent does not take into consideration the real-life problem of caregivers who do not center the wound with respect to the assessment grid in precisely the same manner each time an assessment is undertaken. If one is unable to superimpose one assessment sheet upon another, the lack of a centered assessment complicates the accurate evaluation of wound size.
It is therefore a primary object of the present invention to provide a device and method for wound monitoring that enables the surface area of a wound to be determined, while minimizing a clinician's risk of exposure to contagious or infectious agents present in the wound exudate.
It is a further object of the present invention to provide a device and method for wound monitoring which provide a relatively quick means for removing any wound debris remaining on a device that has come into contact with the wound during use.
A related object of the present invention is to provide a device and method that will reduce the amount of time it takes a clinician to obtain a clean, exudate-free, record of the surface area of a patient's wound.
Yet another object of the present invention is to provide a device and method with the aforementioned features while allowing one to easily and accurately compare of a series of wound assessments.
A further object of the present invention is to provide a device which has the foregoing features, but which is relatively economical to manufacture.
These and other objects and advantages of the present invention, as well as additional inventive features, will be apparent from the description of the invention provided herein.